Label: IBUPROFEN tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-313-24 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 49348-706
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 19, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chances are higher if you
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Do not use
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- the stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- you have asthma
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- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
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- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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- under a doctor's care for any serious condition
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- taking any other drug
When using this product
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- take with food or milk if stomach upset occurs
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- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- any new symptoms appear
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Directions
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- do not take more than directed
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- the smallest effective dose should be used
Adults and children 12 years and older:
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- take 1 tablet every 4 to 6 hours while symptoms persist
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- if pain or fever does not respond to 1 tablet, 2 tablets may be used
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- do not exceed 6 tablets in 24 hours, unless directed by a doctor
Children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - 200 MG Tablet Bottle Label
CommUnityCare Federally Qualified Health Centers
IBUPROFEN
200MG #24
TABLETSDate:
Name:
Dr.Take as directed
123456
1/1/01
IBUPROFEN 200MG #24 TABS NDC 76413-313-24
Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARKFederal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-313(NDC:49348-706) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code I2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-313-24 1 in 1 CARTON 06/24/2003 1 24 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA072096 06/24/2003 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-313) , RELABEL(76413-313)